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A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Castration Resistant Prostate Cancer

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Trial Information

A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer

ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an
experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study
arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to
evaluate differences in the total received dose in relation to the planned dose as a measure
of which of the 2 treatment schedules is superior.

Inclusion Criteria:


- Histological confirmed prostate cancer

- Macroscopic metastatic disease

- Prior treatment with Docetaxel

- Castration resistant disease defined as:Serum testosterone (< 0.5 ng/ml) and:

- Increase in measurable disease (RECIST 1.1, see appendix 10) or

- For non-measurable disease, the appearance of at least one new lesion on nuclear
scintigraphy) or

- A rising PSA from the previous reference value on 2 consecutive occasions at least
one week apart

- Written informed consent

Exclusion Criteria:

- Less than 21 days since prior treatment with chemotherapy

- Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less
than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone
or other new agents.

- Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic
radiotherapy is not an exclusion criteria)

- Persistent adverse events from previous cancer therapies > grade 1 (CTCAE - Version
4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail
changes grade 2 is acceptable)

- ECOG performance status > 1

- Known CNS malignancy

- Within 6 months of randomization:

- myocardial infarction,

- unstable angina,

- angioplasty,

- bypass surgery,

- stroke,

- TIA, or

- congestive heart failure NYHA class III or IV

- Within 3 months prior to randomization:

- treatment resistant peptic ulcer disease,

- infectious or inflammatory bowel disease,

- pulmonary embolism

- Any severe acute or chronic medical condition that places the patient at
increased risk of serious toxicity or interferes with the interpretation of
study results

- History of hypersensitivity to docetaxel or polysorbate 80

- Inadequate organ and bone marrow function as evidenced by:

- Hemoglobin < 9.0 g/dL

- Absolute neutrophil count < 1.5 x 109/L,

- Platelet count < 100 x 109/L,

- AST/SGOT and/or ALT/SGPT > 1.5 x ULN;

- Total bilirubin > 1.0 x ULN,

- Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine
clearance will be calculated according to CKD-EPI formula and patients with
creatinine clearance < 60 mL/min should be excluded ( for
on-line calculation)

- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450
3A4/5. A one week wash out period is necessary for patients who are already on these

- Patients with reproductive potential not implementing accepted and effective method
of contraception.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relative cumulative dose of cabazitaxel at week 18

Outcome Description:

The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays.

Outcome Time Frame:

week 18 after start of treatment

Safety Issue:


Principal Investigator

Jeffrey R Yachnin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Karolinska University Hosptial


Sweden: Medical Products Agency

Study ID:




Start Date:

March 2012

Completion Date:

October 2015

Related Keywords:

  • Metastatic Castration Resistant Prostate Cancer
  • Prostate Cancer
  • Metastatic
  • Castration Resistant
  • Prostatic Neoplasms